Critical Checks for Pharmaceuticals and Healthcare [Part#2]: Is Your Data Reliable Enough to Identify The Root Cause of Impurities?
When manufacturer Shire Pharmaceuticals identified undesirable impurities in rare disease treatments, investigations began: what was guilty, the measurement system or the process? Without understanding the cause, the impurities risked problems with the release of the product not being compliant or affecting patient safety.
From these two real-world case studies, learn how Shire Six Sigma Leader Philippe Noquéro:
- Assessed if operators' visual inspections were correctly detecting a new particle, using Attribute Agreement Analysis (Gage R&R)
- Took the innovate step of using Design of Experiments to determine which factors affect the bias and precision
In this presentation - which is not a software demonstration - Philippe explains his best practices for validating if the measurement system could be eliminated as a root cause. You will learn which statistical tools he uses, and finish the webianr recording with a real world understanding of how you can validate the reliability of your data. (20 minutes)
Ready to watch Part #1 of this 'Critical Checks' series? Click here to watch 'Critical Checks for Pharmaceuticals and Healthcare: Validating Your Data Integrity and Process Performance'